This Funding
Opportunity Announcement (FOA) is a new Request for Applications.

Request
for Applications (RFA) Number: RFA-HS-13-002

NOTICE:
Applications submitted in response to this Funding Opportunity Announcement
(FOA) for Federal assistance must be submitted electronically through
Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R)
forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the
application guidelines included with this announcement in Grants.gov/Apply
for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission
and applicants are highly encouraged to start the process at least four (4)
weeks prior to the grant submission date. See Section IV.

Note regarding Applicability of NIH Grants Policies and Related
Guidance: The policies, guidelines, terms and conditions stated in this FOA
are not identical to those used by the NIH. This FOA will reference NIH grants
policies and guidance where these issuances are applicable or relevant to
submissions.

Catalog of Federal Domestic Assistance Number(s)
93.226

Key Dates
Release/Posted Date: September 7, 2012
Opening Date: November 17, 2012Letters
of Intent Receipt Date(s): November 19, 2012NOTE: On-time submission
requires that applications be successfully submitted to Grants.gov no later
than 5:00 p.m. local time (of the applicant institution/organization). Application Due Date(s): December 17,
2012Peer Review Date(s): Generally four months after receipt dateEarliest
Anticipated Start Date(s):Generally four months after
peer review dateAdditional Information to Be Available Date
(Activation Date):Not ApplicableExpiration Date: December
18, 2012

Due Dates for E.O. 12372

Not
Applicable

Additional
Overview Content

Executive Summary

The
overall goal of the AHRQ Research Career Development program is to help ensure
that a diverse pool of highly trained scientists are available in appropriate
scientific disciplines to address the Nation's health services research needs.

Purpose. The primary purpose of the AHRQ Patient Centered
Outcomes Research (PCOR) Pathway to Independence Award (K99/R00) program is to
increase and maintain a strong cohort of new and talented AHRQ-supported
independent investigators trained in comparative effectiveness methods to
conduct patient care outcomes research. The program is designed to facilitate a
timely transition from a junior non-tenure track faculty or a postdoctoral
research position (or their equivalents) to a stable independent research
career. The program targets investigators
early in their careers to support their development in new sophisticated
methodological comparative effectiveness research skills, interdisciplinary
perspectives, and capabilities in PCOR.

Mechanism of Support. This
FOA will utilize the K99/R00 award mechanism.

Funds Available and Anticipated Number of Awards. Approximately
$1.5 million will be available to support the K99 phase of the award and $3
million for the R00 phase. It is anticipated that AHRQ will make approximately
10 awards. Awards issued under this FOA are
contingent upon the availability of funds and the submission of a sufficient
number of meritorious applications. The total amount awarded and the number of
awards will depend upon the quality, duration and costs of the applications
received.

Budget and
Project Period. The K99 phase will provide support for up to 2 years.
The R00 phase will provide support for up to 3 years. The total project period
may not exceed 5 years. See Section II for details.

PHS 398 Career Development Award
Supplemental Form Component Sections: Specific
Aims are limited to one page. Items 2-4 (Candidate's Background, Career Goals
and Objectives, and Career Development/Training Activities During Award Period)
and Item 11 (Research Strategy) are limited to a combined total of 25 pages,
including tables, graphs, figures, diagrams, and charts. Training in the Responsible Conduct of Research is a
separate attachment and limited to an additional one page.

Eligible Project Director/Principal Investigator (PD/PI): Individuals
with the skills, knowledge, and resources necessary to carry out the proposed
research are invited to work with their institution/organization to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for AHRQ support. The PD/PI must commit a minimum of 75% of full-time
professional effort conducting research and relevant career development activities
specified in the application.

Number of PDs/PIs: Only one PD/PI may be designated
on the application.

Number of Applications:Applicants may have only
one individual Career Development Award application pending peer review at any
time.

Resubmissions: Resubmission
applications are not permitted in response to this FOA.

Renewals:Awards are not renewable and are not transferable from one PD/PI
to another.

Hearing Impaired:Telecommunications
for the hearing impaired are available at: TTY 301-451-5936.

While
grant awards are made to institutions rather than individuals, this
announcement and its instructions are written to inform individual researchers
of this funding opportunity and facilitate the submission of grant applications
by their organizations.

The overall goal of the
AHRQ Research Career Development program is to help ensure that a diverse pool
of highly trained scientists are available in appropriate scientific
disciplines to address the Nation's health services research needs. More
information about AHRQ Career programs may be found at http://www.ahrq.gov/fund/training/trainix.htm.

Section 6301(b) of the Patient Protection and Affordable
Care Act , Public Law 111-148 (the “Affordable Care Act”), enacted Section
937(e) of the Public Health Service Act, authorizing AHRQ to build capacity for
comparative effectiveness research by establishing grant programs that provide
training for researchers in methods used to conduct research.

One of the most
challenging times in a research career is the transition from postdoctoral
trainee to independent scientist. The objective of the AHRQ Patient Centered Outcomes
Research (PCOR) Pathway to Independence Award (K99/R00) initiative is to facilitate a timely transition from a non-tenure
track faculty or a postdoctoral research position (or their equivalents) to a
stable independent research career. The program targets junior investigators early in their
careers to support their development in new sophisticated methodological
comparative effectiveness research skills, interdisciplinary perspectives, and
capabilities in PCOR. Applications
for this award must propose a career development plan that will:

have intrinsic research importance in the area of PCOR (as
described below),

serve as a suitable vehicle for learning sophisticated
comparative effectiveness research methodology(ies), as well as theories and
concepts needed for undertaking a research career in PCOR,

ensure high research productivity; and

sufficiently prepare candidates for PCOR research that is
responsive to and involves stakeholders in the development of the research and
in the dissemination and implementation of research findings. Research
projects conducted by candidates must be designed to provide a strong
foundation for conducting PCOR.

Nature of the Career / Research Transition Opportunity

The K99/R00 award will provide up to 5 years of support
consisting of two phases. The initial mentored phase will provide support
for up to 2 years for very promising and talented eligible emerging junior
investigators who have no more than 5 years of postdoctoral research training
experience at the time of application submission, and do not have a full-time
tenure track assistant professor position (or equivalent). This initial
phase of mentored support will allow the candidate time to obtain additional
training, complete research, publish results, and bridge to an independent
research position. The candidate must propose a research project that
will be pursued during the K99 phase and transition into an independent project
during the R00 phase of the award. The candidate and mentor(s) together will be
responsible for all aspects of the application. An individual may submit
an application from an extramural sponsoring institution/organization that has
a rich and extensive research program in the area of interest as well as the
faculty, facilities and resources to support the proposed research endeavor.
The individual must select an appropriate mentor with a track record of
funded research related to the selected research topic and experience as a
supervisor and mentor. The sponsoring institution must ensure that the
candidate has the protected time needed to conduct the proposed research.
Candidates are required to commit a minimum of 75% of full time professional
effort annually during the mentored phase.

Following the mentored phase, the individual may request
up to 3 years of support to apply CER methods to conduct PCOR research as an
independent scientist at a sponsoring institution/organization to which the
individual has been recruited, been offered and has accepted a tenure-track
full-time assistant professor position (or equivalent). This support is
to allow the individual to continue to work toward establishing his/her own
independent research program in an area which grows out of the mentored phase
research and applies skills gained during the mentored phase. However,
support for the independent phase is not automatic; it is contingent upon being
accepted by an appropriate institution and the successful AHRQ programmatic
review of the individual’s mentored phase of the award.

1. Research Career Training
Objectives

The purpose of PCOR is to improve health outcomes by
developing and disseminating evidence-based information to patients,
clinicians, policy makers, and health care administrators, responding to their
expressed needs about which clinical and health system design interventions are
most effective for which patients under specific circumstances. Research
career training objectives and candidates must focus the content on health care
delivery within the United States.

For purposes of this FOA, PCOR is defined as the conduct
and synthesis of research comparing the benefits and harms of different
interventions and strategies to prevent, diagnose, treat and monitor health
conditions, as well as the delivery of health care in “real world” settings.
The purpose of this research is to improve health outcomes by developing and
disseminating evidence-based information to patients, clinicians, and other
decision-makers, responding to their expressed needs, about which interventions
are most effective for which patients under specific circumstances.

As noted above, Section 937(e) of the Public Health
Service Act authorizes AHRQ to establish a grant program that provides for the
training of researchers in comparative effectiveness methods and states that,
“[a]t a minimum, such training shall be in methods that meet the methodological
standards adopted [by PCORI] under 1181(d)(9) of the Social Security
Act.”

The Methodology Committee of PCORI was established to
develop and improve the science and methods of comparative clinical
effectiveness research. Legislation charges the Committee to develop “a
translation table that is designed to provide guidance and act as a reference
for the Board to determine research methods that are most likely to address each
specific comparative clinical effectiveness research question.”
Grant applicants must be responsive to recommendations made by the Committee in
their grant applications if these are released by the application receipt date
(i.e., applicants must, at a minimum, meet PCORI methodological standards that
are developed.). If these recommendations are released subsequent to the
application receipt date and before the scheduled peer review date, AHRQ will
issue notification that the PCORI standards have been released and will include
any additional submission requirements. A draft report and information on
the activity of the Methodology Committee of PCOR can be found at www.pcori.org.

Note, the Methodology Committee has developed a
preliminary translation framework that will inform the development of the
translation table. Components include:

Determining which research methods are best to address
specific clinical effectiveness research questions;

Utilizing a translational framework to provide
“theoretical underpinnings and organizing structure” to help identify
appropriate analytical designs and methods most suitable for addressing
specific research questions; and,

As necessary, utilization of any translational tool adopted
by PCORI to assist with the dynamic implementation of the translational
framework.

Candidates also need to engage stakeholders (e.g.,
providers, consumers, community groups, payers, purchasers, policymakers,
administrators) in the formulation of their research ( in the development of
research questions, measurement of outcomes, the design of projects, and as
necessary , participation in the research), and to the extent necessary, the
implementation and dissemination of the research. Also, candidates must
demonstrate their ability to collaborate with institutions and networks well
versed in systematic review methodologies or with research centers capable of
performing accelerated clinical effectiveness and outcomes research and the
translation, dissemination and uptake of evidentiary information for health
care practice and decision-making.

Example areas of methodological emphasis could include,
but are not limited to:

Prospective, longitudinal cohort studies of the
effectiveness/comparative effectiveness of health care diagnoses, treatment,
and services including pharmaceuticals, devices and other types of
interventions or combination of interventions;

Cluster-randomized, randomized, or practical clinical
trials of the effectiveness/comparative effectiveness of new or existing health
care technologies, involving wide inclusion of patients and health systems that
adequately reflect health care provision for the general population;

Innovative approaches (clinical, methodological, and
statistical) in the design as well as analysis of studies that more adequately
identify and account for clinical heterogeneity of treatment effects;

Integration of quantitative and qualitative analytical
frameworks and techniques in the screening, synthesis, appraisal, and dissemination/implementation
of evidence;

The identification, role, and assessment of observational
studies in the systematic review and synthesis of evidence on comparative
effectiveness;

Meta-analysis and systematic review methodology;

Decision science modeling and analysis;

The design, analytical tools, and statistical techniques
for reducing, confounding and mitigating the impacts of potential bias inherent
in the observational studies of comparative effectiveness;

The communication of risk and benefit and contextual
information that enhances the use of evidence in decision-making, as well as
the comparative effectiveness of different approaches and technologies in
accomplishing such objective;

Implementation science methodology;

Training in use of registries, combining large-scale
longitudinal data sets, and data mining techniques; and

The ability to conduct subgroup analyses to determine
which treatments and interventions work best for specific populations, such as
underserved and underrepresented groups.

Candidates are strongly encouraged to emphasize and
address the following in their career development programs and applications:

Novel approaches for engaging stakeholder groups (e.g.,
clinicians, consumers, policymakers, insurers, buyers, and administrators) in
the development of research questions, measurement of outcomes, the design of
projects, and, as necessary, participation in the research;

Specific plans for disseminating the findings and
incorporating them into health care delivery at the onset of developing a
research project;

This
FOA will use the Pathway to Independence (K99/R00) award mechanism. The Project
Director/Principal Investigator (PD/PI, also referred to as ‘the Candidate’)
and his/her mentor will be solely responsible for planning, directing, and
executing the proposed project.

AHRQ is not using the Modular Grant Application and Award
Process.Applications submitted in modular format will not be reviewed.

2.
Funds Available

It
is anticipated that AHRQ will make approximately 10 awards. Approximately $1.5
million total costs per year will be available to support the K99 phase of the
awards (up to 2 years) and $ 3 million total costs per year for the R00 phase
(up to 3 years). The total project period may not exceed 5 years. Although the financial plans of the AHRQ provide support
for this program, awards pursuant to this funding opportunity are contingent
upon the availability of funds and the receipt of a sufficient number of
meritorious applications.

Funding
beyond the first year will be contingent upon a review and acceptance by Agency
staff of the annual progress report.

Allowable Costs

The K99/R00 award has two phases: a mentored K99 phase of
up to 2 years at an eligible sponsoring institution/organization, followed by
an independent investigator phase of up to 3 years sponsored by an eligible institution/organization
to which the individual has been recruited.

Mentored Phase of the Pathway to Independence Award
Program (K99)

Candidates are required to commit a minimum of 75% of
full-time professional effort annually (i.e. minimum of 9 person-months) to the
pursuit of their career development and research experience during the mentored
phase. This experience may also include activities such as completing research
publications and searching for an independent research position. Candidates
may engage in teaching and/or clinical duties as part of the remaining 25% of
the candidate’s full-time professional effort not covered by this award, as
long as such duties do not interfere with or detract from the proposed career
development program.

The total salary limit per year for the initial mentored
phase must not exceed $90,000 direct costs, plus associated fringe benefits.
In addition, research support costs up to $25,000 direct costs for each 12
month mentored budget period may be requested.

The research support costs allowed for this program must
be justified and be consistent with the stage of development of the candidate
and the proportion of time to be spent in research or career activities.

Salary must be consistent with the established salary
structure at the institution using its own funds to support other staff members
of equivalent qualifications, rank, and responsibilities in the department
concerned. Fringe benefits should be requested based on the sponsoring
institution’s rate. Research support costs for the mentored phase may include
(a) tuition and fees related to career development; (b) supplies, equipment and
technical personnel; c) travel to research meetings or training; and (d)
statistical services including personnel and computer time.

Salary for mentors, secretarial and administrative
assistance, etc., is not allowed.

The sponsoring institution may supplement AHRQ’s salary
contribution up to a level that is consistent with the institution's salary
scale. However, supplementation may not be from Federal funds unless
specifically authorized by the Federal program from which such funds are
derived. In no case may additional PHS funds beyond those provided in the K99
award be used for salary supplementation. Institutional supplementation of
salary must not require extra duties or responsibilities that would interfere
with the purpose of this award. Under expanded authorities, however,
institutions may rebudget funds within the total costs awarded to cover
salaries consistent with the institution's salary scale. However, the total
salary paid from AHRQ funds may not exceed the legislatively mandated salary
cap. For details, see https://grants.nih.gov/grants/guide/notice-files/NOT-HS-12-007.html

Independent Investigator Phase of the Pathway to Independence Award Program (R00)

Total costs for the independent investigator R00 phase
may not exceed $249,000 per year. This amount includes salary, fringe benefits,
research support and applicable indirect costs.

The candidate is required to devote a minimum of
75% of their full-time, 12 month professional effort annually to research
(i.e., a full-time 9 person-months). However, this effort does not have to
be entirely obtained from the R00 project alone. Recipients
of the R00 phase awards may devote effort to, and receive appropriate salary
from, other research projects so that combined research effort is at least 75% but
does not exceed 100%. If a recipient receives additional
independent research support that would cause his/her other support to exceed
100%, effort on the R00 may be reduced, provided the total
effort devoted to research is at least 75%. Note that a reduction of
effort by 25% or more of the
approved level of effort devoted to the R00 project will require AHRQ prior
approval.

Applicable to both Mentored and Independent Phases

For information regarding AHRQ policy on determining
full-time professional effort for career awards see NOT-OD-04-056. The
requested salary must be consistent both with the established salary structure
at the institution and with salaries actually provided by the institution from
its own funds to other staff members with equivalent qualifications, rank, and
responsibilities in the department concerned. If full-time, 12-month salaries
are not currently paid to comparable staff members, the salary proposed must be
related appropriately to the existing salary structure. Confirmation of salary
is required prior to the issuance of an award. In the K99 phase, salary may
not exceed $90,000 direct costs for the effort devoted to the project (minimum
75% annual effort). Fringe benefits are based on the sponsoring institution’s
rate and the percent of effort and are provided in addition to the salary. (see
also “Eligible Individuals” below).

Indirect Costs: For the extramural K99 phase, these costs,
also known as Facilities and Administrative (F&A) costs, will be reimbursed
at eight percent (8%) of modified total direct costs. For the R00 phase,
indirect costs will be reimbursed at the extramural sponsoring institution’s Federally-negotiated
indirect cost rate. Indirect costs requested by consortium participants are
included in the total cost limitation.

Transition from K99 Phase to R00 Phase Award

Transition from the mentored phase to the independent scientist phase is NOT automatic and is subject to review of the awardee’s research
training/career development accomplishments and an evaluation of the materials
(including progress report) submitted in support of the R00 phase application.
The candidate must have accepted an offer by an eligible institution in a
tenure-track, full-time assistant professor (or equivalent) position in order
to activate the extramural support phase. Information on materials to be
submitted is located in Section VI.2., ‘Activating the Extramural Independent
Investigator Phase of the Pathway to Independence Award (R00)’.

You may submit an application(s) if
your institution/organization has any of the following characteristics:

Public or non-profit private institution, such as a
university, college, or a faith-based or community-based organization;

Units of local or State government;

Indian/Native American Tribal Government (Federally
Recognized);

Indian/Native American Tribal Government (Other than
Federally Recognized);

Indian/Native American Tribally Designated Organizations.

AHRQ’s authorizing legislation does not allow for-profit
organizations to be eligible to lead applications under this research
mechanism. For-profit organizations may participate in projects as members of
consortia or as subcontractors only. Because the purpose of this program is to
improve healthcare in the United States, foreign institutions may participate
in projects as members of consortia or as subcontractors only.
Applications submitted by for-profit organizations or foreign institutions will
not be reviewed. Organizations described in section 501(c) 4 of the
Internal Revenue Code that engage in lobbying are not eligible.

HHS grants policy requires that the grant recipient
perform a substantive role in the conduct of the planned project or program
activity and not merely serve as a conduit of funds to another party or
parties. If consortium/contractual activities represent a significant portion
of the overall project, the applicant must justify why the applicant
organization, rather than the party(s) performing this portion of the overall
project, should be the grantee and what substantive role the applicant
organization will play. Justification can be provided in the Specific Aims or
Research Strategy section of the PHS398 Research Plan Component sections of the
SF424 (R&R) application. There is no budget allocation guideline for
determining substantial involvement; determination of substantial involvement
is based on a review of the primary project activities for which grant support
is provided and the organization(s) that will be performing those activities.

1.B.
Eligible Individuals

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the PD/PI is invited to work
with his/her mentor and organization to develop an application for support.
Individuals from underrepresented racial and ethnic groups as well as
individuals with disabilities are always encouraged to apply for AHRQ support.

By the time of award, the individual must be a citizen or
a non-citizen national of the United States or have been lawfully admitted for
permanent residence (i.e., possess a currently valid Permanent Resident Card
USCIS Form I-551, or other legal verification of such status). Individuals on
temporary or student visas are not eligible for support. It is the grantee
institution’s responsibility to ensure the applicants’ citizenship status.

Candidates must have a
clinical or research doctorate (including Ph.D., M.D., D.O., D.C., N.D.,
D.D.S., D.M.D., D.V.M., Sc.D., D.N.S., Pharm.D. or equivalent doctoral degrees)
and have no more than 5 years of postdoctoral research training at the time of
application.

All candidates must be
at a stage where they require research mentoring and do not have sufficient research experience or institutional
authority to lead an independent research program. This award is intended for and limited to those individuals
who are in mentored training positions and who do not have sufficient research
experience or institutional authority to lead an independent research program.

Both clinical (e.g.,
M.D., D.D.S, Pharm.D., D.O.) and research (e.g., Ph.D. or equivalent) doctorate
holders are eligible if they are: either in a junior non-tenure track faculty
(e.g., Instructor, Assistant Professor) or postdoctoral position; and are not
independent in research. Also, it isrecognized that some institutions
appoint postdoctoral fellows in positions with other titles, although they are
still in non-independent training positions. It is incumbent upon the candidate to provide evidence that the
position he/she occupies complies with the intent of this eligibility
requirement.

Evidence for non-independence may
include:

The candidate’s research is entirely funded by other
investigator’s grants.

The candidate’s research is conducted entirely in another
investigator’s assigned space.

According to institutional policy, the candidate cannot
hire postdoctoral fellows or be the responsible supervisor of graduate
students.

According to institutional policy, the candidate is not
allowed to submit an application as the principal investigator of an AHRQ or
NIH research grant application (e.g., R01 or other equivalent research grant).

The candidate lacks other rights and privileges of
faculty, such as attendance at faculty meetings.

Conversely, evidence for independence, and
therefore lack of eligibility, includes:

The candidate has a full-time tenure track assistant
professor position (or equivalent).

The candidate received a startup package for support of
his/her independent research.

The candidate is eligible to apply for independent
research funding as the principal investigator of an independent PD/PI on AHRQ
or NIH research grants (e.g., R01, R18, R03, R21), or other peer reviewed NIH
or Non-NIH research grants or research contracts over $100,000 direct costs per
year, or project leaders on sub-projects of program project (e.g. P01) or
center (e.g. P30, P50) grants.

All candidates are NOT eligible if they:

Have currently or previously held an independent research
faculty or any tenure-track faculty position, or its equivalent, in academia,
industry or elsewhere; or

Have more than 5 years of postdoctoral research training
(e.g., individual postdoctoral fellowship (F32), postdoctoral appointment on an
institutional training grant (T32) at the time of initial application;

Have been or are an independent PD/PI on AHRQ or NIH
research grants (e.g., R01, R03, R21), career development awards (e.g., K01,
K07, K08, K23, K25), or other peer reviewed AHRQ, NIH or Non-NIH research
grants or research contracts over $100,000 direct costs per year, or project
leaders on sub-projects of program project (e.g. P01) or center (e.g. P30, P50)
grants; or

Have been or are on an institutional mentored career
development award (e.g., KL2, K12).

2. Cost
Sharing or Matching

This program
does not require cost sharing for applications in response to this FOA.

While
there is no cost sharing requirement included in this FOA, AHRQ welcomes
applicant institutions, including any collaborating institutions, to devote
resources to this effort. An indication of institutional support from the
applicant and its collaborators indicates a greater potential of success and
sustainability of the project. Examples of institutional support would
include: donated equipment and space, institutional funded staff time and
effort, or other resource investments. Applicant institutions should indicate
institutional support by outlining the specific contributions to the project
and providing assurances that their organization and any collaborators are
committed to providing these funds and resources to the project. This
information can be included at the end of the budget justification section of
the application, but institutional support dollars are not to be shown/included
in the detailed budget request.

3. Other-Special Eligibility Criteria

Number of Applications

Applicant organizations may submit more than one
application, provided that each application is scientifically distinct.
However, AHRQ reserves the right to support no more than two applications
from the same institution (e.g., university) or its affiliate organizations
(e.g., hospitals, health plans).

AHRQ will not accept any application that is
essentially the same as one already reviewed. An individual may not have more than
one competing AHRQ or NIH career development applications pending review
concurrently. Also, applicants to this program may not concurrently
apply for any other PHS award that duplicates the provisions of this FOA.

Resubmission applications are not permitted in response
to this FOA.

Level of Effort

At the time of award, the candidate must have a
“full-time” appointment at the institution that is the applicant institution.
Candidates who have full time VA appointments and part-time non-VA appointments
are not eligible to apply.

Because of the relatively short duration of the mentored
phase of each of these awards, a request for off-site career development or a
leave of absence lasting more than 3 months, or any other similar request for a
change in status, must receive AHRQ prior approval. Such a request must
address the impact of such action on the awardee’s ability to make sufficient
progress to meet the goals of the award. For example, a request for leave from
a K99 awardee must describe how the leave will affect the awardee’s ability to
transition to the R00 phase of the award.

Mentor

Before submitting the application, the candidate must
identify a mentor who will supervise the proposed career development and
research experience. The mentor should be an active investigator in the area
of the proposed research and be committed both to the career development of the
candidate and to the direct supervision of the candidate’s research. The
mentor must document the availability of sufficient research support and
facilities for high-quality research. Candidates are encouraged to identify
more than one mentor, i.e., a mentoring team, if this is deemed advantageous
for providing expert advice in all aspects of the research career development
program. The mentor, or a member of the mentoring team, should have a
successful track record of mentoring. In such cases, one individual must be
identified as the principal mentor who will coordinate the candidate’s
research. The candidate must work with the mentor(s) in preparing the
application.

Institutional Environment

The applicant institution must have a strong,
well-established record of research and career development activities and
faculty qualified to serve as mentors in patient centered outcomes, health
services, behavioral, or clinical research. The institution must demonstrate a
commitment to the development of the candidate as a productive, independent
investigator and be willing to allow the protected time needed by the
candidate. The candidate, mentor(s), and institution must describe a research
career development program that will maximize the use of this environment,
including available facilities and resources.

Resubmissions.Applicants
are not permitted to submit a resubmission application in response to this FOA.

Renewals.Renewal applications
are not permitted in response to this FOA.

Section
IV. Application and Submission Information

To download a SF424 (R&R)
Application Package and SF424 (R&R) Application Guide for completing the
SF424 (R&R) forms for this FOA, use the “Apply for Grant Electronically”
button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

Registration:

Appropriate
registrations with Grants.gov and eRA Commons must be completed on or before
the due date in order to successfully submit an application. Several of the
steps of the registration process could take four to six weeks. Therefore,
applicants should immediately check with their business official to determine
whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete
by the submission deadline for the application to be considered “on-time” (see
3.C.1 for more information about on-time submission).

A one-time registration is required for
institutions/organizations at both:

The individual designated as PD/PI on the application must be
registered also in the NIH eRA Commons.

The PD/PI must hold a PD/PI account
in the Commons. Applicants should not share a Commons account for both an Authorized
Organization Representative/Signing Official (AOR/SO)
role and a PD/PI role; however, if they have both a PD/PI role and an NIH
Internet Assisted Review (IAR) role, both roles should exist under one Commons account.

The PD/PI at the applicant organization must be affiliated with
that organization. A PD/PI located at another institution need not be
affiliated with the applicant organization, but must be affiliated with their
own organization to be able to access the Commons.

This registration/affiliation must be done by the AOR/SO or
his/her designee who is already registered in the Commons.

Both the PD/PI and AOR/SO need separate accounts in
the NIH eRA Commons since both are authorized to view the application image.

Note: The registration process is not
sequential. Applicants should begin the registration processes for both
Grants.gov and eRA Commons as soon as their organization has obtained a DUNS
number. Only one DUNS number is required and the same DUNS number must be
referenced when completing Grants.gov registration, eRA Commons registration
and the SF424 (R&R) forms.

1. Request Application Information

Applicants must download the SF424 (R&R)
application forms and the SF424 (R&R) Application Guide for this FOA
throughGrants.gov/Apply.

Note: Only the forms package
directly attached to a specific FOA can be used. You will not be able to use
any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA),
although some of the "Attachment" files may be useable for more than
one FOA.

The SF424
(R&R) Application Guide is critical to submitting a complete and accurate
application to AHRQ. Some fields within the SF424 (R&R) application
components, although not marked as mandatory, are required by AHRQ (e.g., the
“Credential” log-in field of the “Research & Related Senior/Key Person
Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific
instructions for such fields are clearly identified in the Application Guide.
For additional information, see “Frequently Asked Questions – Application
Guide, Electronic Submission of Grant Applications.”

The SF424
(R&R) application has several components. Some components are required,
others are optional. The forms package associated with this FOA in Grants.gov/APPLYincludes all applicable components, required and optional.
A completed application in response to this FOA includes the data in the
following components:

When a single institution is involved, follow the
instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions

When multiple institutions
are involved, one institution must be designated as the prime institution and
funding for the other institution(s) must be requested via a subcontract to be
administered by the prime institution. When submitting a detailed budget, the
prime institution should submit its budget using the Research & Related
Budget component. All other institutions should have their individual
budgets attached separately to the Research & Related Subaward Budget
Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application
Guide for further instruction regarding the use of the subaward budget
form.

To allow AHRQ staff to estimate the potential peer review workload and
plan the review (e.g., anticipate the nature of reviewer expertise to be
required), prospective applicants may submit a letter of intent that includes
an acknowledgement of interest in this funding opportunity (please refer to the
number and title of this funding opportunity), a few comments on the subject of
the proposed research, background expertise of key personnel, and the nature
and role of participating institutions. Please include the name and email
address of the Principal Investigator.

This letter of intent
is not required, is not binding, and is not considered in the review of a
subsequent application. However, these letters are administratively very
helpful, as indicated above. To be most useful, the letter of intent is to
be sent by the date listed above and at the beginning of this document.

In order to expedite the review, applicants are requested
to notify the AHRQReferral
Office by email Gerald.Calderone@ahrq.hhs.govwhen the application has
been submitted. Please include the FOA number and title, PD/PI name,
and title of the application.

3.C. Application
Processing

Applications must be received on or before
the application receipt date described above (Section IV.3.A.). If an application
is received after that date, the application may be delayed in the review
process or not reviewed. Upon receipt, applications will be evaluated for completeness
by the Center for Scientific Review, NIH, and AHRQ. Incomplete and/or
non-responsive applications will not be reviewed.

There will be an
acknowledgement of receipt of applications from Grants.gov and the Commons. The
submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the
PI receive Commons acknowledgments. Information on the status of an
application should be checked by the Principal Investigator in the eRA Commons
at: https://commons.era.nih.gov/commons/.

Upon receipt, applications will be evaluated for completeness by the
Center for Scientific Review, NIH, and AHRQ. Incomplete or non-responsive
applications will not be reviewed.

Note: Since email can be unreliable, it is the
responsibility of the applicant to check periodically on the application status
in the Commons.

AHRQ will not accept any
application in response to this funding opportunity that is essentially the
same as one currently pending initial review, unless the applicant withdraws
the pending application. However, when a previously unfunded application,
originally submitted as an investigator-initiated application, is to be
submitted in response to a funding opportunity, it is to be prepared as a NEW
application. That is, the application for the funding opportunity must not
include an “Introduction” describing the changes and improvements made, and the
text must not be marked to indicate the changes from the previous unfunded
version of the application.

Although there is no immediate acknowledgement of the
receipt of an application, applicants are generally notified of the review and
funding assignment within eight (8) weeks.

Use of CMS Data

Purchase of Centers for Medicare and Medicaid Services
(CMS) public-use data, if required, should be discussed in the
application narrative and included in the budget. Projects will ordinarily not
use CMS (Medicare or Medicaid) data involving individual identifiers. However,
for applications that propose to use Medicare or Medicaid data that are individually
identifiable, applicants should state explicitly in the “Research Design
and Methods” section of the Research Plan (form 398) the specific files, time
periods, and cohorts proposed for the research. The applicant should obtain
a cost estimate for the cost of the requested data, if possible. This estimate
will be included in the estimated total cost of the grant at the time funding
decisions are made.

Applicants
should be aware that for individually identifiable Medicare and Medicaid data,
Principal Investigators and their grantee institutions will be required to
enter into a Data Use Agreement (DUA) with CMS to protect the confidentiality
of data in accordance with the terms of the DUA and applicable law.

In developing research plans, applicants should allow
time for refining, obtaining approval, and processing of their CMS data
requests. Requests may take six months from the time they are submitted to
complete. Applications proposing to contact beneficiaries or their providers
require the approval of the CMS Director and may require meeting(s) with CMS
staff.

CMS data are provided on IBM mainframe tapes using the
record and data formats commonly employed on these computers. Applicants should
either have the capability to process these tapes and formats or plan to make
arrangements to securely convert them to other media and formats.

Questions regarding CMS data should be directed to the
AHRQ program official listed under Agency Contacts (see Section VII).

To avoid double counting, applicants should not
include the cost of identifiable CMS data in the budget. In the event
the total costs of the project plus the cost of CMS data is greater than the
total cost cap of this FOA, the budget for the project will be adjusted so that
the total costs awarded to the recipient plus the CMS data costs do not exceed
the cost cap.

For
efficient grant administration, AHRQ grant administration procedures will be
used and conducted in accordance with the terms and conditions, cost
principles, and other considerations described in the HHS Grants Policy
Statement. The Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm

Pre-award costs are allowable. A
grantee may, at its own risk and without AHRQ prior approval, incur obligations
and expenditures to cover costs up to 90 days before the beginning date of the
initial budget period of a new award if such costs are necessary to conduct the
project and would be allowable under the grant, if awarded, without AHRQ prior
approval. If specific expenditures would otherwise require prior approval, the
grantee must obtain AHRQ approval before incurring the cost. AHRQ prior
approval is required for any costs to be incurred more than 90 days before the
beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on AHRQ either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. AHRQ expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.

NRSA Support: Ruth L. Kirschstein National Research
Service Award (NRSA) recipients who are selected for K99/R00 award funding must
terminate their NRSA support prior to receiving support from the K99/R00 award.

The applicant organization
must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with
Grants.gov. For additional information, see “Frequently Asked Questions
– Application Guide, Electronic Submission of Grant Applications.”

PHS398 Research Plan Component
Sections

All application instructions outlined in the SF424 (R&R)
Application Guide (See Supplementary
Instructions for Research Career Awards, Part I.7.5) that are not otherwise specified within this Funding
Opportunity Announcement are to be followed, incorporating
"Just-in-Time" information concepts, and with the following
additional requirements:

Specific Aims is limited to 1 page.

Items 2-4 (Candidate's Background, Career Goals and
Objectives and Career Development/Training Activities During Award Period) and
Item 11 (Research Strategy) are limited to a combined total of 25 pages,
including tables, graphs, figures, diagrams, and charts. Training in
the Responsible Conduct of Research is a separate attachment and limited to one
additional page.

While each section of the Candidate Information and
Research Strategy components needs to be uploaded separately as a PDF
attachment, applicants are encouraged to construct the Candidate Information
component and the Research Strategy component as a single document, separating
sections into distinct PDF attachments just before uploading the files.This
approach will enable applicants to better monitor formatting requirements such
as page limits.

The following
information must be included in the application:

Project Summary/Abstract
(Component of the Other Project Information Component)

This attachment must be uploaded via the
Other Project Information Component, and must include a description of your
current research and the research you propose to continue in the independent
phase.

Candidate’s Background
(Component of Candidate Information)

Describe the candidate’s commitment to a career in the
application of comparative effective methods to patient centered outcomes research.

Describe the candidate’s potential to develop into a
successful independent investigator.

Describe the candidate’s current as well as long-term
research and career objectives.

If currently supported by an institutional or individual
Ruth L. Kirschstein NRSA or institutional career development award (e.g., K12,
Kl2), describe the candidate’s current research training, fellowship, or career
development program.

For individuals in postdoctoral positions with other titles
although still in non-independent training positions, describe evidence of
non-independence.

Career Goals and
Objectives (Component of Candidate Information)

Present a systematic plan that: (1) shows a logical
progression from the candidate’s prior research and training experiences to the
training and research experiences proposed for the mentored phase of the award
(K99) and subsequently to independent investigator status (R00); (2) justifies
the need for further mentored career development to become an independent
research investigator; and (3) that utilizes the relevant research and
educational resources of the institution.

Candidates should consult with the proposed mentor to
discuss the proposed research training/career development plan for the mentored
phase and the research plan to be presented in the application for the
subsequent independent scientist phase.

Career
Development/Training Activities During Award Period (Component of Candidate
Information)

Describe the career development plan and how it fits with
the candidate’s goals and prior experience. A systematic plan should be
presented for obtaining the necessary comparative effectiveness methods
training and expertise to launch an independent research career in PCOR. The
career development plan must be specifically tailored to meet the needs of the
candidate and the ultimate goal of achieving independence as a researcher.

Describe the current training activities and how they
relate to the career development plans and the career goals of the candidate.
Candidates must justify the need for the award, both the mentored phase and the
independent scientist phase, and must provide a convincing case that the
proposed period of support (1-2 years as a mentored candidate followed by up to
3 years as an independent scientist) will substantially enhance his/her career
and/or will allow the pursuit of a novel or promising approach to a particular PCOR
problem using CER methods.

The candidate should describe how the career development
plan will promote the candidate’s success and scientific independence in the
application of CER methods to PCOR. This plan should describe activities such
as those that will lead to new and/or enhanced research, grant-writing, and communication
skills and knowledge. The candidate should also describe how these skills will
contribute to research productivity and facilitate the development of new
approaches and directions for investigation. Courses or other activities that
might allow the candidate to expand the scope of his/her research in order to
improve the potential for success in gaining further independent funding are
particularly encouraged.

The candidate must describe the plan for evaluation of
his/her progress during the mentored phase and for the transition to the independent
phase.

The candidate and K99 phase mentor (see below) must
describe plans for the transition to the independent phase.

Training in the
Responsible Conduct of Research

Applications must include a plan to obtain instruction in
the responsible conduct of research.

This section should document prior instruction in
responsible conduct of research during the applicant’s current career stage
(including the date of last occurrence) and propose plans to receive
instruction in responsible conduct of research.

Such plans must address five instructional components,
format, subject matter, faculty participation, duration of instruction, and
frequency of instruction. This information is outlined and explained in NOT-OD-10-019.

The plan may include career stage-appropriate,
individualized instruction or independent scholarly activities that will
enhance the applicant’s understanding of ethical issues related to their
specific research activities and the societal impact of that research.

The role of the sponsor/mentor in responsible conduct of
research instruction must be described. Applications lacking a plan for
instruction in responsible conduct of research will be considered incomplete
and may be delayed in the review process or may not be reviewed .

The background, rationale and more detail about
instruction in the responsible conduct of research can be found in NOT-OD-10-019.

The candidate must name a primary mentor (sponsor), who,
together with the candidate, is responsible for the planning, direction, and
execution of the K99 phase program. The candidate may also identify co-mentors
as appropriate to the goals of the program.

The primary mentor should be recognized as an
accomplished investigator in the proposed research area and have a track record
of success in training individuals in postdoctoral positions who have gone on
to become independent investigators.

The mentor should have sufficient independent research
support to cover the costs of the proposed research project in excess of the
allowable costs of this award.

The application must include a statement from the
mentor(s) that provides: 1) information on their research qualifications and
previous experience as a research supervisor; 2) a plan that describes the
nature of the supervision and mentoring that will occur during the proposed
award period, including how the candidate’s scientific and professional
independence will be promoted; 3) a description of the elements of the planned
research training, including any formal course-work; and 4) a plan for
transitioning the candidate from the mentored phase to the independent
scientist phase of the award.

Similar information must be provided by any co-mentor. If
more than one mentor is proposed, the respective areas of expertise and responsibility
of each should be described. Co-mentors should describe clearly how they will
coordinate with the primary mentor and the candidate.

The mentor must agree to provide annual evaluations of
the candidate’s progress for the initial mentored phase as required in the
annual progress report.

The mentor must agree to review and comment on the
extramural independent scientist (R00) phase application (See Section below on
Activating the Independent Phase of the Pathway to Independence Award (R00).

Consultant(s)/Collaborator(s): Signed statements must be
provided by each consultant/collaborator confirming their participation in the
project and describing their specific roles. Collaborators and consultants
generally do not need to provide their biographical sketches. However,
information should be provided clearly documenting the appropriate expertise in
the proposed areas of consulting/collaboration. Collaborators/consultants are
generally not directly involved in the development of the career of the candidate
as an independent investigator.

Description of
Institutional Environment (Component of Environment and Institutional
Commitment to the Candidate)

The sponsoring institution must document a strong,
well-established research and career development program related to the
candidate's area of interest, including a high-quality research environment
with key faculty members and other investigators capable of productive
collaboration with the candidate.

Describe the sponsoring institution’s scientific
environment including the resources and facilities that will be available to
the candidate.

Describe how the institutional research environment is
particularly suited for the development of the candidate's research career and
the pursuit of the proposed research plan and progression to the R00 phase.

Institutional Commitment
to the Candidate’s Research Career Development (Component of Environment and
Institutional Commitment to the Candidate)

The sponsoring institution must provide a statement of
commitment to the candidate's development into a productive, independent
investigator and to meeting the requirements of this award. It should be clear
that the institutional commitment to the candidate is not contingent upon
receipt of the K99/R00 award.

Provide assurances that the candidate will be able to
devote a minimum of 9 person-months (75% of full-time professional effort) to
the development of their research program. The remaining effort should be
devoted to activities related to the development of the candidate’s career as
an independent scientist.

Provide assurance that the research facilities,
resources, and training opportunities, including faculty capable of productive
collaboration with the candidate, will be available for the candidate’s planned
career development and research programs.

Provide appropriate time and support for any proposed
mentor(s) and/or other staff consistent with the career development plan.

Research Strategy (Component of Research
Plan)

The candidate should describe his/her research capability
that is relevant to the proposed R00 research plan. Ideally, this would include
a brief description of research and research training performed prior to the
mentored phase, a description of the research and research training planned
during the mentored phase, and a detailed description of the research planned
for the independent phase. This narrative should describe what the candidate
will accomplish during the mentored phase that will enable him/her to conduct
the planned independent research program proposed and launch an independent
research career.

The research description should demonstrate not only the
quality of the candidate’s research thus far but also the novelty,
significance, creativity and approach of the R00 phase research, as well as the
ability of the candidate to carry out the research. Consequently, the research
plan should provide a detailed rationale, experimental approach and plan for
the independent phase research.

The application must also describe the relationship
between the mentor’s research and the candidate’s proposed research plan. The
application should describe how the candidate will gain independence from
his/her mentors and achieve separation of his/her scientific research program
from that of the mentor(s).

If more than one K99 phase mentor is proposed, the
respective areas of expertise and responsibility should be described.

Candidates must carefully follow the SF424 (R&R)
Application Guide, including the time period for when letters of reference will
be accepted Applications lacking the required reference letters will not be
reviewed (this information is described in: NOT-OD-11-036).
Please note that the specified format must be used. This is a separate process
from submitting an application electronically. Reference letters are submitted
directly through the eRA Commons Referee
Information link and not through Grants.gov.

Budget Component

Special
Instructions for Modular Grant applications

AHRQ is not using the Modular Grant Application and Award
Process. Applicants for funding from AHRQ should ignore application
instructions concerning the Modular Grant Application and Award Process, and
prepare applications using instructions for the Research and Related Budget
Components of the SF 424 (R&R). Applications submitted in the Modular
format will not be reviewed.

Budget Component (Section 4.7): Use the SF424 (R&R) Detailed Budget component
and review the instructions found in Part I.4.7(R&R Budget Component) of
the Application Guide. However for “K” applications only limited budget
information is required; therefore, candidates will also need to follow the
special instructions in Part I.7.4 of the SF 424 (R&R) [Supplemental
Instructions for Career Development Awards], noting the special instructions
that modify Section 4.7. In budget section A (Senior/Key Persons) include
base salary, person months and requested salary and fringe benefit information
for only the candidate. Base salary, and requested salary and fringe
benefits should reflect actual levels. Any adjustments based on AHRQ
policy limits will be made at the time of the award. Sections B-E should
be left blank. If a dollar amount is required, enter 0 (zero) in the
appropriate box. The total Research Development Support amount requested
for each year will be entered in Section F, Materials and Supplies. In
Section H enter Modified Total Direct Costs under “Indirect Cost Type.”
The Indirect Cost rate is 8% of modified total direct cost. The Indirect
Cost amount should be entered under “Funds Requested.” Totals for
Sections F, G, and H will be calculated automatically for each year as well as
for the Cumulative Budget. Within the direct cost limitation for research
development support, provide a detailed description with justification for all
equipment, supplies and personnel that will be used to help achieve the career
development and research objectives of this award.

Warning: Please
be sure that you observe the total cost, project period, and page number
limitations specified above for this FOA. Application processing may be delayed
or the application may be rejected if it does not comply with these
requirements.

Do
not use the Appendix to circumvent the page limitations of the Research Plan
component. An application that does not comply with the required page
limitations may be delayed in the review process.

Resource Sharing Plan(s)

The precise content of the data-sharing plan will vary,
depending on the data being collected and how the investigator is planning to
share the data. Applicants who are planning to share data may wish to
describe briefly the expected schedule for data sharing; the format of the
final dataset; the documentation to be provided; whether or not any analytic
tools also will be provided; whether or not a data-sharing agreement will be
required and, if so, a brief description of such an agreement (including the
criteria for deciding who can receive the data and whether or not any
conditions will be placed on their use); and the mode of data sharing (e.g.,
under its own auspices by mailing a disk or posting data on its institutional
or personal website or through a data archive or enclave). Investigators
choosing to share under their own auspices may wish to enter into a
data-sharing agreement. References to data sharing may also be
appropriate in other sections of the application.

The reasonableness of the data sharing plan or the
rationale for not sharing research data will be assessed by the
reviewers. However, reviewers will not factor the proposed data sharing
plan into the determination of scientific merit or the priority score.

Priority Populations

The Healthcare Research and Quality Act of 1999, in
amending the Public Health Service Act, directed AHRQ, in carrying out its
mission, to conduct and support research and evaluations, and to support
demonstration projects, with respect to the delivery of health care in
inner-city and rural areas (including frontier areas), and health care for
priority populations. Priority populations include low income groups; minority
groups; women; children; the elderly; and individuals with special health care
needs, including individuals with disabilities and individuals who need chronic
care or end-of-life health care. This authority is found at 42 USC
299(c). To implement this statutory mandate, AHRQ published a Notice in
the NIH Guide on February 28, 2003, establishing a new Agency policy on the
Inclusion of Priority Populations in health services research (see https://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html).
Applicants under this FOA should consider and discuss including priority
populations in the research design as specified in this Notice. AHRQ policy
also requires that women and members of minority groups be included in all
AHRQ-supported research projects involving human subjects, unless a clear and compelling
rationale and justification is provided that inclusion is inappropriate with
respect to the health of the subjects or the purpose of the research.

Publication Transmittal: General AHRQ Requirements

In keeping with the Agency's efforts to translate the
results of AHRQ-funded research into practice and policy, grantees are to
inform the AHRQ Office of Communications and Knowledge Transfer (OCKT) when
articles from their AHRQ-supported activities are accepted for publication in
the professional literature. Grantees should also discuss any ideas about
other dissemination and marketing efforts with OCKT staff. The goal is to
ensure that efforts to disseminate research findings are coordinated with other
Agency activities to maximize awareness and application of the research by
potential users, including clinicians, patients, health care systems and
purchasers and policymakers. This is critical when outreach to the
general and trade press is involved. Accordingly, contact with the media
will take place with close coordination between OCKT and the press offices of
the grantee's institutions. In cases when products are created (such as
annual or final reports, Web-based tools, CD-ROMs), grantees will be asked to
submit to OCKT a brief plan describing how the product will be
publicized. An OCKT staff person will be assigned to each product and
will coordinate the implementation of the plan, especially issues related to
printing and electronic dissemination, and outreach to the media.

Assessment of AHRQ Grant Programs

In carrying out its stewardship of research programs,
AHRQ may request information essential to an assessment of the effectiveness of
Agency research programs. Accordingly, grant recipients are hereby
notified that they may be contacted after the completion of awards for periodic
updates on publications resulting from AHRQ grant awards, and other information
helpful in evaluating the impact of AHRQ-sponsored research.

AHRQ expects grant recipients to keep the Agency informed
of publications, as well as the known uses and impact of their Agency-sponsored
research. Applicants must agree to notify AHRQ immediately when a manuscript
based on research supported by the grant is accepted for publication, and to
provide the expected date of publication as soon as it is known, regardless of
whether or not the grant award is still active.

HCUP & MEPS

Applicants are encouraged to make use of
AHRQ’S Healthcare Cost and Utilization Project (HCUP) or the Medical
Expenditure Panel Survey (MEPS). HCUP is a family of health care
databases and related software tools and products developed through a
Federal-State-Industry partnership. HCUP databases bring together the
data collection efforts of State data organizations, hospital associations, private
data organizations, and the Federal government to create a national information
resource of patient-level health care data. HCUP databases provide data
beginning in 1988 and contain encounter-level information for all payers
compiled in a uniform format with privacy protections in place. HCUP
includes three nationwide databases, the Nationwide Inpatient Sample (NIS) and
the Kids’ Inpatient Database (KID), and the Nationwide Emergency Department
Sample (NEDS), and three types of State databases, the State Inpatient
Databases (SID), the State Ambulatory Surgery Databases (SASD), and the State
Emergency Department Databases (SEDD). More information on HCUP can be
found at http://www.hcup-us.ahrq.gov/home.jsp.

The MEPS is conducted to provide nationally
representative estimates of health care use, expenditures, sources of payment,
and insurance coverage for the U.S. civilian, non-institutionalized
population. MEPS is composed of three component surveys: the Household
Component (HC), the Medical Provider Component (MPC), and the Insurance
Component (IC). The Household Component is the core survey, and it
forms the basis for the MPC sample and part of the IC sample. The MEPS IC
collects data on health insurance plans obtained through employers and unions,
including the number and types of private insurance plans offered, employer
characteristics, premiums, and contributions by employers and employees.
More information on the MEPS is available at http://www.meps.ahrq.gov.

Applicants’ use of HCUP and/or MEPS data does not
preclude the use of secondary data sources or primary data collection.

Health Literacy

AHRQ encourages
applicants to write Informed Consent (IC) and HIPAA Authorization documents for
research to be understandable to all potential research participants, including
those with low levels of literacy and limited English proficiency.
AHRQ recommends that IC and Authorization documents be written in accordance
with health literacy principles, and that IC and Authorization documents be
available in multiple languages if potential research participants include
individuals with limited English proficiency. AHRQ also recommends adopting a
process to verify potential research participants’ understanding.

IC documents must
provide information in language understandable to potential participants (45 CFR 46.116). For covered entities under the Privacy Rule, authorization documents
must include core elements and required statements in 45 CFR 164.508(c) and must be written in plain language. The AHRQ
Informed Consent and Authorization Toolkit for Minimal Risk Research (http://www.ahrq.gov/fund/informedconsent/) provides sample forms and guidance on adapting
them, and also describes an appropriate process for obtaining informed consent
and authorization.

Consumer Products

All consumer products
produced under an AHRQ-funded grant should be appropriate for the target
audience. This includes individuals from diverse cultural, language, and literacy
backgrounds. Audience testing should be part of the development process.
AHRQ’s Talking Quality website (http://www.talkingquality.gov/) and AHRQ’s guide and checklist for developers
and purchasers of health information (IT) that is designed to be accessed and
used by consumers (http://healthit.ahrq.gov and select Health IT Tools) are resources
applicants can use to ensure appropriateness of consumer products.

Section V. Application Review Information

1.
Criteria

Administrative Criteria:
Upon receipt, applications will be reviewed by AHRQ for completeness and
responsiveness.

Merit Review Criteria: Merit Review Criteria, as described below, will
be considered in the review process.

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be
evaluated for scientific and technical merit by an appropriate peer review
group convened in accordance with standard AHRQ peer review procedures that are
described in 42 CFR Part 67, Subpart A. Incomplete and/or non-responsive
applications or applications not following instructions given in this FOA will not
be reviewed.

As part of the initial merit review, all applications
will:

Undergo a selection process in which only those
applications deemed to have the highest scientific merit will be discussed
and assigned a priority score

Receive a written critique

The
mission of AHRQ is to improve the quality, safety, efficiency, and effectiveness
of health care for all Americans. As part of this mission, applications
submitted to AHRQ to support health services research are evaluated for
scientific and technical merit through the AHRQ peer review system.

Review Criteria

The overall goal of AHRQ-supported
career development programs is to help ensure that diverse pools of highly
trained scientists are available in adequate numbers and in appropriate
research areas to address the Nation’s PCOR needs. The scientific review
group will address and consider each of these criteria in assigning the
application's overall impact/priority score, weighting them as appropriate for
each application.

Overall Impact

Reviewers will provide
an overall impact/priority score to reflect their assessment of the likelihood
for the individual proposed career development plan to exert a sustained,
powerful influence on the activities involved, in consideration of the
following five scored review criteria, and additional review criteria (as
applicable for the proposed program).

Scored Review
Criteria

Reviewers will consider each of the five review criteria
below in the determination of scientific merit, and give a separate score for
each. An application does not need to be strong in all categories to be
judged likely to have major scientific impact. For example, a project
that by its nature is not innovative may be essential to advance a field. These
criteria are listed in logical order and not in order of priority.

Candidate

Career Development Plan/Career Goals and Objectives

Research Plan

Mentor, Co-Mentor(s), Consultant(s) and Collaborator(s)

Environment and Institutional Commitment to the
Candidate

Candidate:

What is the candidate’s record of research
productivity, including the quality of peer-reviewed scientific
publications?

What is the quality of the candidate's pre- and
postdoctoral research training experience, including expertise gained?

Based on the candidate’s experience, track record
and prior research training, what is the candidate’s potential to become
an outstanding, successful independent investigator who will contribute
significantly to the application of CER methods to PCOR on topics that are
directly applicable to improving health care delivery?

To what extent does the application provide evidence
of the candidate’s research creativity, and does this evidence suggest
that the candidate has the potential to develop a creative, independent
research program?

Given the candidate’s prior training, proposed
career development plan, and the referees’ evaluations, is it reasonable
to expect that the candidate will be able to achieve an independent,
tenure-track or equivalent position within the time period requested for
the K99 phase of this award?

Do the letters of reference from at least three
well-established scientists address the above review criteria, and do they
demonstrate evidence that the candidate has a high potential for becoming
an independent investigator?

Relative to the above review criteria, how do these
scientists evaluate the candidate?

Do the letters provide strong evidence that the
candidate has a high potential to become an independent investigator?

Career Development Plan/Career Goals &
Objectives:

Are the content and duration of the proposed
didactic and research components of the career development plan
appropriate for the candidate’s current stage of scientific and
professional development and proposed research career goals?

Is the proposed career development plan likely to
contribute substantially to the scientific and professional development of
the candidate including his/her successful transition to independence?

How does the proposed career development plan
enhance or augment the applicant’s training and/or career development to
date?

Is the additional proposed training needed and
appropriate for the proposed research plan and the applicant’s future
career plans?

To what extent are the plans for evaluating the K99
awardee’s progress adequate and appropriate for guiding the applicant
towards a successful transition to the independent phase of the award?

Is the timeline planned for the transition to the
independent phase of the award appropriate for the candidate’s current
stage of scientific and professional development and the career
development proposed for the K99 phase of the award?

Research Plan:

Is the proposed K99 phase research significant?

Are the scientific and technical merits of the K99
research question, experimental design and methodology appropriate for the
candidate’s level of training, an appropriate vehicle for developing the
research skills described in the career development plan, and appropriate
for developing a highly successful R00 research program?

Is the proposed R00 phase scientifically sound and a
logical extension of the K99 phase? Does the capability of the applicant
and experience gained from the K99 phase appropriately equip the candidate
to successfully complete the proposed R00 plans? Is there evidence of
long-term viability of the proposed R00 phase research plan?

Does the R00 phase project address an existing
health care delivery issue, as described in the Research Objectives
section?

Is the R00 phase project original and innovative?
Does the project develop or employ novel concepts, approaches,
methodologies, tools, or technologies in comparative effectiveness
research?

Is the project responsive to and does it involve appropriate
stakeholders in the development of the research and in the dissemination
and implementation of research findings?

To what extent is the proposed R00 phase research
likely to contribute significantly to our understanding of patient
centered outcomes research issues?

To what extent is the proposed R00 phase research
likely to foster the career of the candidate as an independent
investigator in patient centered outcomes?

Mentor/Co-Mentor(s), Consultant(s), and
Collaborator(s):

To what extent does the mentor have a strong track
record in training future independent researchers?

To what extent are the mentor’s research
qualifications and experience, scientific stature, and mentoring track
record appropriate for the applicant’s career development needs?

Do(es) the mentor(s) adequately address the above
review criteria including the candidate’s potential as well as his/her
strengths and areas needing improvement?

Is the proposed supervision that will occur during
the mentored phase of support adequate, and is the commitment of the
mentor(s) to the applicant’s continued career development appropriate?

Does the mentor have a comprehensive plan to support
the proposed K99 phase career development and research plans as well as
the candidate’s efforts to transition to independence? Is this plan
adequate and appropriate?

Are the consultants’/collaborators’ research and/or
mentoring qualifications appropriate for their roles in the proposed K99
phase of the award?

Environment and Institutional Commitment to
the Candidate:

To what extent does the institution provide a high
quality environment for the candidate’s development?

To what extent are the research facilities and
educational opportunities, including collaborating faculty, adequate and
appropriate for the candidate’s research and career development goals
during the K99 phase of the award? What evidence is provided that the K99
sponsoring institution is strongly committed to fostering the candidate’s
development and transition to the independent (R00) phase?

Is there adequate assurance that the required
minimum of 9 person-months (75% of the candidate’s full-time professional
effort) will be devoted directly to the research training, career
development, and research activities described in the proposed career
development and research plans?

2.A.
Additional Review Criteria

In addition to the above criteria,
the following items will be addressed and considered in the determination of
scientific merit and the rating:

Degree of Responsiveness.How well does the application address the purpose and
objectives of this FOA? How responsive is the application to the special
eligibility criteria, including the project requirements, noted in the FOA?

Protection of Human Subjects
from Research Risk. The involvement of human subjects and protections
from research risk relating to their participation in the proposed research
will be assessed. See the “Human Subjects Sections” of the PHS398 Research
Plan component of the SF424 (R&R). For research that involves human subjects but
does not involve one of the six categories of research that are exempt under 45
CFR Part 46, the committee will evaluate the justification for involvement of
human subjects and the proposed protections from research risk relating to
their participation according to the following:

1) Risks to the subjects,
likelihood & seriousness:

Are all risks
identified?

Are all subject pools
identified (e.g., are providers subjects)?

2) Adequate protection from risks:

Is there evidence of adequate
data security?

Are there special
populations that need protections?

3) Potential benefits to subjects and others:

Has the PD/PI
identified all anticipated benefits?

4) Importance of the knowledge to be gained:

Does the project
propose to provide social benefit?

5) For research involving interventions with human subjects where
there is a greater than minimal risk, reviewers will review and comment on:

Adequacy of the
proposed Data and Safety Monitoring plan

Any proposed monitoring
function, such as monitoring committees, or boards.

For research that
involves human subjects and meets the criteria for one or more of the six
categories of research that are exempt under 45 CFR Part 46, the committee will
evaluate: 1) the justification for the exemption, 2) human subjects involvement
and characteristics, and 3) sources of materials.

evaluate the
proposed plan and justification for the inclusion of priority populations
or evaluate the proposed justification when priority populations are
absent.

evaluate the
proposed exclusion of priority populations when a requirement for
inclusion would be inappropriate with respect to the purpose of the
research.

evaluate the
plans for outreach and recruitment of study participants where
appropriate.

evaluate the
proposed plan for conducting subgroup analyses so that study results will
be relevant to one or more priority populations where appropriate.

include these
criteria as part of the scientific assessment and assigned score.

Privacy and Security Protections for
Patients. The resources and processes to be used to
address privacy and security issues in the development and implementation of
the intervention will be assessed.

2.B.
Additional Review Considerations

As applicable for the project proposed, reviewers will
address each of the following items, but will not give scores for these items
and should not consider them in providing an overall impact/priority score.

Training in the Responsible Conduct of Research.Taking into
account the specific characteristics of the career development program, level
of candidate experience, and the particular circumstances of the candidate, the
reviewers will address the following questions. Does the plan
satisfactorily address the format of instruction, e.g., lectures, coursework
and/or real-time discussion groups? Do plans include a sufficiently broad
selection of subject matter, such as conflict of interest, authorship, data
management, human subjects and animal use, laboratory safety? Do the
plans adequately describe how faculty will participate in the instruction?
Does the plan meet the minimum requirements for RCR, i.e., eight contact hours
of instruction every four years? Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of
the review committee.

Budget and Period of Support.Reviewers will
consider whether the budget and the requested period of support are fully
justified and reasonable in relation to the proposed research.

2.C. Resource Sharing
Plan(s)

Data Confidentiality

The AHRQ confidentiality statute, 42 USC 299c-3(c),
requires that information that is obtained in the course of AHRQ supported
activities and that identifies individuals or establishments be used only for
the purpose for which it was supplied. Information that is obtained in the
course of AHRQ-supported activities and that identifies an individual may be
published or released only with the consent of the individual who supplied the
information or is described in it. There are civil monetary penalties for violation
of the confidentiality provision of the AHRQ statute 42 USC 299c-3(d). In
the Human Subjects section of the application, applicants must describe
procedures for ensuring the confidentiality of the identifying information to
be collected. The description of the procedures should include a
discussion of who will be permitted access to this information, both raw data
and machine readable files, and how personal identifiers and other identifying
or identifiable data will be restricted and safeguarded. Identifiable
patient health information collected by grantees under this FOA will also be
obtained and managed in accordance with the HIPAA Privacy Rule, 45 CFR Parts
160 and 164. These regulations serve to limit the disclosure of personally
identifiable patient information by covered entities and define when and how
such information can be disclosed e.g., to researchers. Thus, health care
plans ordinarily will require either patient authorization for disclosures of
identifiable information to be made to researchers or waivers of such
authorizations obtained from an IRB or Privacy Board (defined in the
regulations), which will involve review to ensure that identifiable health
information will be appropriately safeguarded by the investigators. The
DHHS Office of Civil Rights is the enforcement body for this regulation.
Additional information about the regulations, their implementation, and
alternative methods of permissible disclosures to researchers (limited data
sets with data use agreements, de-identified data sets, data about deceased
persons, and data use to develop protocols) can be obtained from: http://www.hhs.gov/ocr/hipaa/

The grantee should ensure that computer systems
containing confidential data have a level and scope of security that equals or
exceeds that established by the HIPAA Security Rules if applicable (see HIPAA
website in prior paragraph) and that established by the Office of Management
and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal
Automated Information Systems. The National Institute of Standards and
Technology (NIST) has published several implementation guides for this
circular. They are: An Introduction to Computer Security: The NIST Handbook;
Generally Accepted Principals and Practices for Securing Information Technology
Systems; and Guide for Developing Security Plans for Information Technology
Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/. The
applicability and intended means of applying these confidentiality and security
standards to subcontractors and vendors, if any, should be addressed in the
application.

Sharing Research Resources: Rights
in Data

Unless otherwise provided in grant awards, AHRQ grantees
may copyright, or seek patents for, as appropriate, final and interim products
and materials developed in whole or in part with AHRQ support, including, but
not limited to, methodological tools, measures, software with documentation,
literature searches, and analyses. Such copyrights and patents are subject to
a royalty-free, non-exclusive, and irrevocable AHRQ license to reproduce,
publish, use or disseminate for any purpose consistent with AHRQ’s statutory
responsibilities and to authorize others to do so for any purpose consistent
with AHRQ’s statutory responsibilities. In accordance with its
legislative dissemination mandate, AHRQ purposes may include, subject to statutory
confidentiality protections, making project materials, databases, results, and
algorithms available for verification or replication by other researchers. In
addition, subject to AHRQ budget constraints, final products may be made
available to the health care community and the public by AHRQ or its agents if
such distribution would significantly increase access to a product and thereby
produce substantial or valuable public health benefits. Ordinarily, to
accomplish distribution, AHRQ publicizes research findings but relies on
grantees to publish research results in peer-reviewed journals and to market
grant-supported products. AHRQ's Office of Communications and Knowledge
Transfer (OCKT) wishes to be consulted in advance of publication in order to
coordinate announcements of new AHRQ-supported research results with other AHRQ
dissemination activities. Important legal rights and requirements
applicable to AHRQ grantees are set out or referenced in AHRQ's grants
regulation at 42 CFR Part 67, Subpart A (available in libraries and from the
GPO's website at http://www.gpoaccess.gov/cfr/index.html),
which incorporates additional applicable provisions on Rights in Data,
including 45 CFR Part 74 and 37 CFR Part 401.

Selection
Process

Applications submitted in response to this funding
opportunity will compete for available funds with all other recommended
applications. The following will be considered in making funding decisions:

Scientific merit of the proposed project as determined by
peer review

Availability of funds

Responsiveness to goals and objectives of the FOA

Relevance to program priorities

Programmatic, institutional and geographic balance

Portfolio balance within AHRQ and DHHS

NOTE: AHRQ reserves the right to support no more than
two applications from the same institution (e.g., university) or its affiliate
organizations (e.g., hospitals, health plans).

After the
peer review of the application is completed, the PD/PI will be able to access
his or her Summary Statement (written critique) via the NIH eRA Commons.

If the application is under consideration for funding,
AHRQ will request "Just-In-Time" information from the
applicant. Just-In-Time information generally consists of information on
other support, any additional information necessary to address administrative
issues, and certification of IRB approval of the project's proposed use of
human subjects. For details, applicants may refer to the "AHRQ
Revised Policy for Institutional Review Board (IRB) Review of Human Subjects
Protocols in Grant Applications" (https://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html).

Once all administrative and programmatic issues have been resolved, a formal
notification in the form of the Notice of Award (NoA) will be generated
via email notification from the awarding component to the grantee business
official at the applicant organization. The NOA signed by the AHRQ grants
management officer is the authorizing document.

Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NOA are at the recipient’s risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See also Section IV.5., “Funding
Restrictions.”

Any application
awarded in response to this FOA will be subject to the DUNS, CCR Registration,
and Transparency Act requirements as noted on the as noted on the AHRQ web site
at http://www.ahrq.gov/fund/postawrd.htm#terms.

2. Administrative and National Policy Requirements

All AHRQ grant and cooperative agreement awards are subject to AHRQ’s
grants regulations at 42 CFR Part 67, Subpart A, and are subject to the
requirements of the HHS Grants Policy Statement that are applicable based on
the recipient type and the purpose of this award (see http://www.ahrq.gov/fund/hhspolicy.htm).

As necessary,
additional Terms and Conditions will be incorporated into the award statement.

Activating the Independent Phase of the Pathway to Independence Award (R00)

Transition from the mentored phase to the independent
phase is intended to be continuous in time and, except in unusual
circumstances, (e.g., candidate is waiting to transition to an offered and
accepted, permanent tenure-track or equivalent position), AHRQ will not extend
the K99 phase beyond the 2-year limit. To activate the independent phase of the
grant, individuals must have been offered and accepted a tenure-track,
full-time assistant professor position (or equivalent) at an eligible
institution with appropriate infrastructure to support the proposed research
program and a history of external research funding.

The application for the R00 phase of the award must be
submitted by the independent phase (R00) grantee organization no later than 2
months prior to the proposed activation date of the R00 award. However, to
avoid potential problems in activation, candidates are strongly encouraged to
contact their AHRQ program official as soon as plans to assume an independent
position develop, and not later than 6 months prior to the termination of the
K99 phase of the award, to discuss plans for transition to, and the application
for, the R00 phase.

The independent phase institution will submit an
application on behalf of the candidate for the R00 award using the PHS398
Application. The R00 application must include:

A new face page signed by the R00 phase institutional
representative;

A new project description page (the project summary or
abstract should be updated to reflect current plans for the R00 phase);

Detailed budget pages and budget justification;

Biographical sketches;

A new Resources page;

A brief description of progress made during the K99 phase
that will serve as the Final Progress Report for the K99 phase;

An updated research plan (the specific aims should be
updated to reflect current plans for the R00 phase and the updated research
plan should be briefly described in less than 5 pages); and

A new checklist.

In addition, a letter from the R00 Department or Division
Chairman (or equivalent) describing the R00 institution’s commitment to the
candidate and plans for his/her career development should be submitted (see
below), as well as a final evaluation statement by the K99 phase mentor, if not
already provided.

These materials should be sent directly to AHRQ. The
original application plus one copy are to be mailed to the Grants Management
contact person listed in the Notice of Award. The R00 application will be
evaluated by program staff for completeness and responsiveness to the program.

An institutional commitment agreement will be required at the time of
activation of the independent phase of the award. This agreement should satisfy
the criteria described in the Career Development Award Section 7 of the SF424 Application
Guide. In addition to space, facilities, resources, and other
support needed to conduct the proposed research, the sponsoring institution
must provide protected research time (minimum of 9 person-months (75% of the
candidate’s full-time professional effort) annually for the duration of the R00
award.

The start-up package and other institutional support must
be described and should be comparable to that given to other faculty (or
equivalent research position on other eligible institutions) recently hired
into tenure-track or equivalent positions. Institutions must provide a startup
and salary package equivalent to that provided to a newly hired faculty member
(or equivalent research position on other eligible institutions) who does not
have a grant; R00 funds may not be used to offset the typical startup package
or to offset the usual institutional commitment to provide salary for
tenure-track assistant professors (or equivalent in nonacademic settings) who
are hired without grant support. The R00 sponsoring institution should describe
the candidate’s appointment, bearing in mind that it must be tenure-track assistant
professor (or equivalent), and confirm that the appointment is not contingent
on the transfer of the award to the institution. The R00 phase institution must
foster and support the awardee’s ability to apply for and secure independent
research grant (e.g. R01) support.

The R00 award requires that a minimum of 9 person-months (75% of the
candidate’s full-time professional effort) be devoted annually to research
activities. Consequently, teaching, clinical duties and other non-research
activities should be minimal during the R00 award period. AHRQ staff may review
start-up packages and other commitments between the institution and candidate
prior to activating the independent phase of the award. It is suggested that
the applicant and/or the hiring institution discuss the institutional
commitment with the AHRQ program official prior to submission of the R00
application. AHRQ will not activate the independent phase if the institutional
commitment is deemed inadequate. Applicants who are approved to transition will
receive a Notice of Award reflecting the new R00 grant mechanism, the dollar
amount, and the new recipient organization (if applicable).

The K99/R00 award is intended to facilitate successful transition to
independence. Consequently, a requirement for activation of the R00 phase is
successful completion of this transition. Applicants are encouraged (but not
required) to apply for independent positions at departments and institutions
different from where they conducted their mentored research. It is important
for all applicants, but especially so for applicants who intend to stay at the
mentored phase institution for the independent phase, to provide a plan by
which they will separate from their mentor and advance to independence.
Applicants are also encouraged to include a plan and timeline for submitting an
independent research grant application in a research area relevant to the
mission of AHRQ.

Candidates who are not approved to transition will receive written notification
from the awarding component communicating the rationale for the disapproval.
This letter typically will be sent within 60 days of receipt of the R00
application.

Although the financial plans of AHRQ provide support for this program, awards
pursuant to this funding opportunity are contingent upon the availability of
funds.

Termination of the K99 award phase

If transition from the K99 phase at an eligible
sponsoring institution to the R00 phase occurs at the originally scheduled end
date of the K99 award, then no specific steps to terminate the K99 award are
necessary. If the transition occurs prior to the scheduled end date, then a
revised Notice of Award will be issued to terminate the K99 phase award.
Carry-over of unspent funds from a partially completed year in the K99 phase
into the R00 phase will not be permitted.

The annual progress reports must include Sections A
through J as described in the general PHS form 2590 instructions. For details regarding progress report
submission, refer to http://www.ahrq.gov/fund/noncomp.htm. If instructions on the AHRQ website
are different from the PHS form 2590 instructions, follow the instructions on
the AHRQ website.

The Progress Report is to include descriptive and
evaluative comments on both completed activities and plans for the remainder of
that year, including any changes foreseen in the future. At a minimum,
the reports will include descriptive comments on: progress to date
measured against project aims; methodological changes implemented; key
preliminary findings; significant problems and resolutions; inclusion of
priority populations; and project related publications, presentations, and
dissemination activities. AHRQ will provide the timetable for these progress
reports.

Please note:
The Research Performance Progress Report (RPPR) is a Federal-wide progress
report which will eventually replace the PHS 2950. Grantees will be required to
follow the new progress report guidelines when they become available.

Expenditure data is to be reported on the
Federal Financial Report (FFR; SF 425). AHRQ requires annual financial
expenditure reports for ALL grant programs as described in the HHS Grants
Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm). AHRQ implementation of the FFR
retains a financial reporting period that coincides with the budget period of a
particular project. However, the due date for annual FFRs will be 90 days
after the end of the calendar quarter in which the budget period ends.
Note that this is a change in due dates of annual FFRs and may provide up to 60
additional days to report, depending upon when the budget period end date falls
within a calendar quarter. For example, if the budget period ends
4/30/2013, the annual FFR is due 9/30/2013 (90 days after the end of the
calendar quarter of 6/30/2013).

A final Progress Report, Invention Statement and Federal
Financial Report are required when an award ends. For further details
regarding grant closeout requirements, refer to http://www.ahrq.gov/fund/closeout.htm.

Other Reporting Requirements

Evaluation: In carrying out its stewardship of
human resource-related programs, AHRQ may request information essential to an
assessment of the effectiveness of this Program. Accordingly, recipients
are hereby notified that they may be contacted after the completion of this
award for periodic updates on various aspects of their employment history, publications,
support from research grants or contracts, honors and awards, professional
activities, and other information helpful in evaluating the impact of the
research training program.

Other Income: Awardees may
retain royalties and fees for activities such as scholarly writing, service on
advisory groups, honoraria from other institutions for lectures or seminars,
fees resulting from clinical practice, professional consultation or other
comparable activities, provided these activities remain incidental, are not
required by the research and research-related activities of this award, and
provided that the retention of such pay is consistent with the policies and
practices of the grantee institution.

All other income and fees, not included in the preceding paragraph as
retainable, may not be retained by the career award recipient.

Usually, funds budgeted in an AHRQ-supported research grant for the
salaries or fringe benefits of individuals, but freed as a result of a career
award, may not be re-budgeted. The awarding component will give consideration
to approval for the use of released funds only under unusual circumstances. Any
proposed retention of funds released as a result of a career award must receive
prior written approval of the AHRQ awarding component.

Leave Policies: Leave to
another institution from which the career development is taking place,
including a foreign laboratory, may be permitted if the proposed experience is
directly related to the purpose of the award.

A copy of a letter or other evidence from the institution where the
leave is to be taken must be submitted to assure that satisfactory arrangements
have been made. Support from the career award will continue during such leave.

Leave without award support may not exceed 12 months. Such leave
requires the prior written approval by AHRQ and will be granted only in unusual
situations.

Support from other sources is permissible during the period of leave
without award support. Such leave does not reduce the total number of months of
program support for which an individual is eligible.

Publication and Sharing of Research Results: AHRQ
supports the practical application and sharing of outcomes of funded
research. Therefore, grantees should make the results and accomplishments
of their career development activities available to the research community and
to the public at large. The grantee organization should assist grantees
in these activities, including the further development of discoveries and
inventions for furthering research and benefiting the public. No
restrictions should be placed on the publication of results in a timely manner.

Candidates are encouraged to submit reports of their
findings for publication to the journals of their choice. For each
publication that results from a trainee’s research, AHRQ support must be
acknowledged by a footnote in language similar to the following: “This
investigation was supported by the Agency for Healthcare Research and Quality
(AHRQ) under National Research Service Award (number). Its contents are
solely the responsibility of the authors and do not necessarily represent the
official views of the AHRQ.”

The Federal Funding
Accountability and Transparency Act of 2006 (Transparency Act), includes a
requirement for awardees of Federal grants to report information about
first-tier subawards and executive compensation under Federal assistance awards
issued in FY2011 or later. All awardees of applicable grants and cooperative
agreements are required to report to the Federal Subaward Reporting System (FSRS)
available at www.FSRS.gov on all
subawards over $25,000. See the AHRQ Grants Process web site at http://www.ahrq.gov/fund/postawrd.htm#terms for additional information on this reporting
requirement.

Section VII. Agency Contacts

We encourage your inquiries
concerning this funding opportunity and welcome the opportunity to answer
questions from potential applicants. Inquiries may be written or by telephone,
and fall into three areas: scientific/research (program), peer review, and
financial or grants management issues.

1.
Scientific/Research Contact(s):

Direct your questions about general FOA issues, including information on
the inclusion of priority populations to:

Federal regulations at 45 CFR Part 46 require that
applications and proposals involving human subjects research must be evaluated
in accordance with those regulations, with reference to the risks to the
subjects, the adequacy of protection against these risks, the potential
benefits of the research to the subjects and others, and the importance of the
knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

The Department of Health and Human Services (DHHS)
"Standards for Privacy of Individually Identifiable Health Information", regulation was mandated by the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 which governs the protection of individually
identifiable health information. It is administered and enforced by the
DHHS Office for Civil Rights (OCR). The OCR website (http://www.hhs.gov/ocr/) provides information
on the Privacy Rule, including a complete Regulation Text and a set of decision
tools that may be used to determine whether a researcher is a staff member of a
covered entity.

Access to Research Data through the Freedom of Information Act:

OMB Circular A-110 provides access to certain research
data developed with Federal support through the Freedom of Information Act (FOIA), 5 U.S.C. 552, in certain circumstances. Data that are (1) first
produced in a project that is supported in whole or in part with Federal funds
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation or
administrative order) may be accessed through FOIA. If no Federal action is
taken having the force and effect of law in reliance upon an AHRQ-supported
research project, the underlying data are not subject to this disclosure
requirement. Furthermore, even if a Federal regulatory action is taken in
reliance on AHRQ-supported research data, disclosure of such data is limited in
accordance with the AHRQ Confidentiality Statute, 42 USC 299c-3(c). NIH has
provided general related guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm,
which does not include discussion of the exception applicable to confidential
identifiable data collected under AHRQ's authorities.

Should applicants wish to place data collected under this
FOA in a public archive, which can provide protections for the data (e.g., as
required by confidentiality provisions of the statute applicable to
AHRQ-supported projects, 42 USC 299c-3(c)) and manage the distribution of
non-identifiable data for an indefinite period of time, they may. The
application should include a description of any archiving plan in the study
design and include information about this in the budget justification section
of the application. In addition, applicants should consider how to structure
informed consent statements or other human subject protection procedures to
permit or restrict disclosures of identifiable data, as warranted.

Healthy People 2020:

The Public Health Service (PHS) is committed to achieving
the health promotion and disease prevention objectives of "Healthy People
2020," a PHS-led national activity for setting health improvement
priorities for the United States. AHRQ encourages applicants to submit grant
applications with relevance to the specific objectives of this initiative.
Potential applicants may obtain a copy of "Healthy People 2020" at http://www.health.gov/healthypeople.

Authority and Regulations:

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to
the intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under the authority of 42 USC 299 et
seq. and, 42 CFR Part 67 and in accordance with 45 CFR Parts 74 or 92 and
other referenced applicable statutes and regulations. All awards are
subject to the terms and conditions, cost principles, and other considerations
described in the HHS Grants Policy Statement. The HHS Grants Policy Statement
can be found at http://www.ahrq.gov/fund/hhspolicy.htm.

The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the Public Health Service mission to protect and advance the physical and
mental health of the American people.